MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00532935
First received: September 19, 2007
Last updated: February 20, 2015
Last verified: February 2015

September 19, 2007
February 20, 2015
January 2008
October 2009   (final data collection date for primary outcome measure)
Change From Baseline in A1C at Week 32 [ Time Frame: Baseline and Week 32 ] [ Designated as safety issue: No ]
A1C is measured as a percent. Thus this change from baseline reflects the Week 32 A1C percent minus the baseline A1C percent
Not Provided
Complete list of historical versions of study NCT00532935 on ClinicalTrials.gov Archive Site
  • Change From Baseline in Fasting Plasma Glucose (FPG) at Week 1 [ Time Frame: Baseline and Week 1 ] [ Designated as safety issue: No ]
    Change from baseline reflects the Week 1 FPG minus the baseline FPG. At Week 1, the dose was 50/500 mg b.i.d. for Sita/Met FDC and 30 mg q.d. for pioglitazone
  • Change From Baseline in 2-hour Post-Meal Glucose (PMG) at Week 32 [ Time Frame: Baseline and Week 32 ] [ Designated as safety issue: No ]
    Change from baseline reflects the Week 32 2-hour PMG minus the baseline 2-hour PMG
  • Change From Baseline in FPG at Week 32 [ Time Frame: Baseline and Week 32 ] [ Designated as safety issue: No ]
    Change from baseline reflects the Week 32 FPG minus the baseline FPG
  • Percent of Participants With A1C <7.0% at Week 32 [ Time Frame: Week 32 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
MK0431A vs. Pioglitazone in Patients With Type 2 Diabetes Mellitus (0431A-066)
A Phase III Randomized, Active-Comparator (Pioglitazone) Controlled Clinical Trial to Study the Efficacy and Safety of the MK0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin) in Patients With Type 2 Diabetes Mellitus

A study to evaluate the efficacy and safety of MK0431A in comparison to a commonly used medication in patients with type 2 diabetes

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: sitagliptin phosphate (+) metformin hydrochloride
    sitagliptin phosphate (+) metformin hydrochloride 50/500 mg tablet bid, titrating up to sitagliptin phosphate (+) metformin hydrochloride 50/1000 mg tablet for an ~32 wk treatment period
    Other Name: Janumet
  • Drug: Comparator: pioglitazone
    pioglitazone 30 mg tablet qd, titrating up to 45 mg qd for an ~32-wk treatment period.
    Other Name: pioglitazone
  • Experimental: 1
    Sitagliptin phosphate (+) metformin hydrochloride
    Intervention: Drug: sitagliptin phosphate (+) metformin hydrochloride
  • Active Comparator: 2
    pioglitazone
    Intervention: Drug: Comparator: pioglitazone
Wainstein J, Katz L, Engel SS, Xu L, Golm GT, Hussain S, O'Neill EA, Kaufman KD, Goldstein BJ. Initial therapy with the fixed-dose combination of sitagliptin and metformin results in greater improvement in glycaemic control compared with pioglitazone monotherapy in patients with type 2 diabetes. Diabetes Obes Metab. 2012 May;14(5):409-18. doi: 10.1111/j.1463-1326.2011.01530.x. Epub 2011 Dec 22.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
517
October 2009
October 2009   (final data collection date for primary outcome measure)

General Inclusion Criteria:

  • Patient has type 2 diabetes mellitus
  • Patient is inadequately controlled and not on treatment with insulin or oral antihyperglycemic therapy

General Exclusion Criteria:

  • Patient has a history of type 1 diabetes mellitus or history of ketoacidosis
  • Patient was on antihyperglycemic agent therapy (oral or insulin) within the prior 12 weeks
  • Patient was on >4 weeks (cumulatively) of antihyperglycemic therapy (oral or insulin) over the prior 3 years
Both
18 Years to 78 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States,   Korea, Republic of,   Philippines,   Israel,   Poland,   Russian Federation,   United Kingdom,   Costa Rica,   Malaysia,   Ireland,   Puerto Rico,   Sweden,   Thailand,   Austria,   Peru,   Slovenia,   Hungary,   Turkey
 
NCT00532935
0431A-066, 2007_510
Not Provided
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
February 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP